In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial. However, there’s a growing recognition of the benefits of utilizing the same DSMB members to oversee multiple trials within an entire therapeutic program. This shift to a single DSMB for a therapeutic program not only ensures con ..read more

Clinical trials are the cornerstone of medical advancements, but ensuring their integrity and safety requires meticulous oversight. Data monitoring committees (DMCs, also known as data safety monitoring boards [DSMBs]) play a crucial role in this process, providing independent evaluation of unmasked trial data to safeguard patient welfare during the trial. The Food and Drug Administration’s (FDA’s) February 2024 draft guidance Use of Data Monitoring Committees in Clinical Trials signals a significant shift in approach. Open for public comment until April 15, 2024, this draft seeks to modernize ..read more

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. This leaves it up to individual institutional review boards (IRBs) to establish a definition, policies/procedures, and reporting requirements for sponsors, contract research organizations (CROs), and investigative sites to follow. Understandably, this can cause confusion for researchers working with multiple IRBs. It’s important to make sure you’re familiar with your IRB’s reporting requirements—and if you’re not sure, it’s always appropriate to reach o ..read more

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible and the participants have the most up to date information so they can decide whether to continue their participation in the research study. These responsibilities and reporting requirements are outlined in U.S. regulations. However, it’s not always clear to research professionals what should be reported, who should do the reporting, and which oversight entity(ies) should review the report. In 2009, the Food and Drug Administration (FDA) released a guidance document on AE rep ..read more

The site-sponsor relationship continues to become more important day by day. With trial complexity increasing, site staff availability stretched thin, bespoke methods of interaction, and unique methods of engaging with patients administered by sites, the relationship is complicated. While considering how to engage the global and very unique set of partners, we often silo down to the term “sites.” However, each site is different, and sponsors and contract research organization (CRO) study teams must continually evaluate how they engage uniquely with each sites and find ways to make collaboratio ..read more

During the course of study conduct, most research involving human participants will require some form of planned modification or revision. This includes amendments involving changes to institutional review board (IRB)-approved protocols. The investigator is responsible for ensuring changes receive IRB review prior to implementation; the IRB is responsible for reviewing the changes to ensure everything continually approves the regulatory criteria. There are various IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications. Additionally, res ..read more

Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate with research site teams to activate and execute clinical trials. Despite each stakeholders’ best efforts, there are persistent challenges regularly throwing studies off track and resulting in costly workarounds: Failure to achieve recruitment goals: About 20 to 50% of clinical trials will require “rescue”, where new sites are added to cure patient enrollment shortfalls. Ensuring every selected site can achieve their recruitment targets ..read more

In clinical trials, time is both an ally and an adversary. Efficient site initiation can make or break the success of a trial. Centralized processes are essential in expediting these timelines, bringing together standardized workflows, advanced technology, and meticulous quality assurance. There are many benefits of a centralized CTMS business operations team, which acts as a hub for resources, updates, and information related to clinical trial management. An intuitive intake form, data accuracy, custom reporting, and streamlined decision-making processes can collectively help reduce bottlenec ..read more

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research, oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. In this blog, we examine how mRNA can impact cancer treatment, the unique challenges associated with w ..read more

There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. Eliminating the requirement for manual data transcription leads to significant savings in terms of the costs and time spent on a study. However, adopting eSource is challenging for many research facilities. Successfully implementing eSource requires sites to shift from paper-based data to electronic data records in a way to preserve data integrity and patient safety. Best Practices for Implementing eSource eSource must be implemented in a way to ensure ..read more